Sheila F O'Brien1, Yves Grégoire2, Josiane Pillonel3, Whitney R Steele4, Brian Custer5, Katy L Davison6, Marc Germain2, Antoine Lewin7, Clive R Seed8. 1. Epidemiology & Surveillance, Canadian Blood Services, Ottawa, ON, Canada. 2. Medical Affairs and Innovation, Hema-Quebec, Quebec, QC, Canada. 3. Direction des Maladies Infectieuses, Sante Publique France, St Maurice, France. 4. Transmissible Disease Department, American Red Cross, Rockville, MD, USA. 5. Epidemiology and Health Science, Vitalant Research Institute, San Francisco, CA, USA. 6. Immunisation, Hepatitis & Blood Safety, Health Protection Agency, London, UK. 7. Medical Affairs and Innovation, Hema-Quebec, Montreal, QC, Canada. 8. Donor and Product Safety (DAPS) Policy Unit, Australian Red Cross Blood Service, Perth, WA, Australia.
Abstract
BACKGROUND AND OBJECTIVES: In Canada, the deferral for men who have sex with men (MSM) was decreased from a permanent deferral to a 5-year then a 12-month deferral. Current HIV testing can detect an HIV infection in donated blood within 2 weeks of exposure; thus, a 12-month deferral may be unnecessarily restrictive. We aimed to estimate the residual risk of HIV if the deferral were further decreased to 3 months. MATERIALS AND METHODS: Using a deterministic model with stochastic Monte Carlo simulation, residual risk of HIV was the sum of testing error, assay sensitivity and window-period risks. Data inputs were estimated from donor surveillance, donor surveys and published data. Residual risk was modelled at baseline and using three scenarios: (1) most likely - non-compliance, HIV prevalence and incidence rates of MSM are unchanged; (2) optimistic - non-compliance improves by 50%; and (3) pessimistic - non-compliance, HIV prevalence and incidence rates of MSM all double. RESULTS: HIV residual risk at baseline was 1 in 36·0 million donations (95% CI 1 in 1 504 907 million, 10·5 million); in the most likely scenario 1 in 34·2 million (1 in 225 534 million, 8·7 million); in the optimistic scenario 1 in 36·0 million (1 in 282 618 million, 9·5 million); in the pessimistic scenario 1 in 16·7 million (1 in 39 469 million, 6·0 million). All confidence intervals overlapped. CONCLUSION: With very low modelled risk under a 12-month deferral, the additional risk with a 3-month deferral is very low. This is true even with a pessimistic scenario.
BACKGROUND AND OBJECTIVES: In Canada, the deferral for men who have sex with men (MSM) was decreased from a permanent deferral to a 5-year then a 12-month deferral. Current HIV testing can detect an HIV infection in donated blood within 2 weeks of exposure; thus, a 12-month deferral may be unnecessarily restrictive. We aimed to estimate the residual risk of HIV if the deferral were further decreased to 3 months. MATERIALS AND METHODS: Using a deterministic model with stochastic Monte Carlo simulation, residual risk of HIV was the sum of testing error, assay sensitivity and window-period risks. Data inputs were estimated from donor surveillance, donor surveys and published data. Residual risk was modelled at baseline and using three scenarios: (1) most likely - non-compliance, HIV prevalence and incidence rates of MSM are unchanged; (2) optimistic - non-compliance improves by 50%; and (3) pessimistic - non-compliance, HIV prevalence and incidence rates of MSM all double. RESULTS: HIV residual risk at baseline was 1 in 36·0 million donations (95% CI 1 in 1 504 907 million, 10·5 million); in the most likely scenario 1 in 34·2 million (1 in 225 534 million, 8·7 million); in the optimistic scenario 1 in 36·0 million (1 in 282 618 million, 9·5 million); in the pessimistic scenario 1 in 16·7 million (1 in 39 469 million, 6·0 million). All confidence intervals overlapped. CONCLUSION: With very low modelled risk under a 12-month deferral, the additional risk with a 3-month deferral is very low. This is true even with a pessimistic scenario.
Authors: Eduard Grebe; Michael P Busch; Edward P Notari; Roberta Bruhn; Claire Quiner; Daniel Hindes; Mars Stone; Sonia Bakkour; Hong Yang; Phillip Williamson; Debra Kessler; Rita Reik; Susan L Stramer; Simone A Glynn; Steven A Anderson; Alan E Williams; Brian Custer Journal: Blood Date: 2020-09-10 Impact factor: 22.113